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Quality Management System for Medical Devices

For achieving and maintaining ISO 13485:2016,
CE Mark or U.S.QSR (21CFR 820) for 510(K)
Compliance Success

The Purpose of a Quality Management System

A well-managed QMS is paramount to success.

qmsWrapper is a quality workflow process based system
that not only fosters a team-based approach to compliance but
introduces an innovative approach to managing QMS,
called Managing Through Quality or MTQ - 
the more effective and efficient way to manage your QMS.

The QMS Workflow Processes reduce:

 - Errors

 - Forgotten paperwork

 - Missed QMS reports

Your team should not guess what to do next;
it should be defined for them,
monitored and managed automatically.

MTQ helps to coordinate, control and direct
your organization’s tasks and activities,
to help you not only meet your customer’s quality
requirements but also your regulatory
and compliance requirements.

MTQ supports a team focused approach to QMS,
ensures everyone works together towards
desired quality outcomes and fosters a culture of team-based compliance. 

Everyone is involved!

"We invented qmsWrapper because we needed what you need:
a system to help get your projects done in time, and stay FDA or ISO compliant."

In qmsWrapper, Quality Management is integrated with Project,
Document and Risk management - in other words,
QMS is sewn into the fabric of each module.

They exist both as separate modules
so you can work within each as needs arise, but
also they exist as highly integrated and interconnected
to maximize productivity and provide
a seamless team based compliance experience.

 

 

Benefits of qmsWrapper Quality Management System

qmsWrapper provides a step by step sequence of tasks
with appropriate guides to help you correctly perform the quality manager’s tasks.

  • MTQ (Manage Through Quality) - an innovation in management practices
    that use Project and QMS workflow processes
    to help quality managers achieve compliance.
  • QMS Processes driven Project Management and
    defined QMS Workflow Processes
    make ISO 13485 and FDA QSR compliance easier.
    (adaptable to ISO:9001)
  • Tagged as a QMS process or milestone,
    the tasks can be followed and backtracked
    to show what tasks were undertaken
    to resolve QMS related issues within the context of the Project itself.
    It creates a full circle of follow-up and coordination,
    fostering collaboration and continuous improvement.
  • Built-in Workflow Process Editor -
    gives you the freedom to build your own Workflow Processes.
  • Role-Based Security - ensures specified access to tasks,
    projects and associated content. Documents are controlled and
    stored according to their related projects.
  • Real-Time Visibility - a real-time visual overview of all user tasks -
    percentage
    did, reports and assignments.
    Monitor who does what with what efficiency.
    Instantly identify any overlaps in the work and
    easily reassign tasks as needed, follow the over-all productivity and
    keep track of milestones, QMS issues, deadlines,
    upcoming events, to-dos and due dates at a glance. 

  • The electronic trail for data - A signed document,
    electronic or otherwise, now has a date stamped electronic trail,
    which is required and can be printed.
  • With the QMS Approval Workflows,
    automatic notifications are sent to the QMS Manager for approval.
    They are fully customizable!
    Create a new approval workflow or attach an existing one
    to meet FDA 510k or ISO 13485 compliance.
  • Mirrored. Projects in the Project Management Module are mirrored in both,
    the Document Management Module and in the Quality Management module.
    This mirroring creates a simple way for the QMS Manager
    to follow, monitor and track all QMS events in and for any project. 
  • Built-in Team Messaging - Purpose-built and designed
    to support Team compliance.
    Chats and chat files are actually linked to particular projects or tasks -
    the simplest way to document any issue and save any Chat as a meeting
    to a particular project, complete with meeting minutes, agenda,
    scheduling, follow-up actions,
    add special ISO and FDA QSR attributions.
    Remain one step closer to full compliance.
  • Risk Management. The Project Management Module
    is directly connected to the Risk Management Module
    to ensure ISO and FDA compliance.

qmsWrapper fosters a team collaboration based approach
to FDA 510k and ISO 13458 compliance - for better project productivity!  

 

 

Compliance Made Easy

Implementing a quality management system affects every aspect of your organization's performance. qmsWrapper is a holistic, flexible and scalable solution, created to address organization’s unique needs.

With overarching benefits and advantages like helping to communicate a readiness to produce consistent results, preventing mistakes, reducing costs, ensuring that processes are automated, defined and controlled, you are continually improving your organization.

Your QMS controls will have a direct impact on your design outputs, as well as your verification and/or validation activities.

 

 

qmsWrapper offers a full circle of QMS.